Pharma Focus Asia

Pfizer and Astellas Pharma Announce FDA Priority Review for XTANDI®

Thursday, August 24, 2023

Pfizer and Astellas Pharma have recently announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental new drug application (sNDA) for XTANDI® (enzalutamide).

This drug is being considered for the treatment of patients with non-metastatic castration-sensitive prostate cancer (nmCSPC), which is also referred to as non-metastatic hormone-sensitive prostate cancer (nmHSPC), especially in cases with high-risk biochemical recurrence (BCR).

If the sNDA is approved, XTANDI will become the first novel hormone therapy to gain FDA approval for treating this earlier stage of prostate cancer. The primary aim of this treatment is to delay the spread of cancer cells to other parts of the body. 

Clinical trials have demonstrated that the addition of XTANDI to leuprolide (a common hormonal therapy) provides greater clinical benefits compared to using placebo in combination with leuprolide.

The trial successfully achieved its primary goal of showing improved metastasis-free survival (MFS) for the group that received XTANDI plus leuprolide. This combination demonstrated a significant 58 percent decrease in the risk of metastasis (the spread of cancer) or death when compared to the placebo plus leuprolide group.

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